Volume 12.28 | Jul 18

Cell Therapy News 12.28, July 18, 2011
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory | Events
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Precision Gene Targeting in Stem Cells Corrects Disease-Causing Mutations
Using two distinct methods, researchers have successfully and consistently manipulated targeted genes in both human embryonic stem cells and induced pluripotent stem cells. [Press release from the Whitehead Institute for Biomedical Research discussing online prepublication in Cell and Nature Biotechnology]


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Case Western Reserve University School of Medicine Restores Breathing After Spinal Cord Injury in Rodent Model
Researchers bridged a spinal cord injury and biologically regenerated lost nerve connections to the diaphragm, restoring breathing in an adult rodent model of spinal cord injury. [Press release from Case Western Reserve University School of Medicine discussing online prepublication in Nature]

Efficient Process Using MicroRNA Converts Human Skin Cells into Neurons, Study Shows
The addition of two particular gene snippets to a skin cell’s usual genetic material is enough to turn that cell into a fully functional neuron, report researchers. [Press release from Stanford School of Medicine discussing online prepublication in Nature]

Editing the Genome
Researchers developing genome-scale editing tools have rewritten the genome of living cells using the genetic equivalent of search and replace—and combined those rewrites in novel cell strains, strikingly different from their forebears. [Press release from Harvard Medical, Dental and Public Health Schools discussing online prepublication in Science]

Stem Cell Breakthrough Heralds New Era of Therapy Development
Scientists have uncovered a new method for culturing adult stem cells which could lead to the creation of revolutionary stem cell therapies for conditions such as arthritis, Alzheimer’s disease and Parkinson’s disease. [Press release from the University of Glasgow discussing online prepublication in Nature Materials]

Stem Cell “Memory” Can Boost Insulin Levels
Researchers capitalizing on the “memories” of stem cells generated from adult cells to bring new hope to sufferers of juvenile or type 1 diabetes. [Press release from Tel Aviv University discussing online prepublication in Cell Stem Cell]

Stem Cells Restore Cognitive Abilities Impaired by Brain Cancer Treatment
Research with rats found that stem cells transplanted two days after cranial irradiation restored cognitive function, as measured in one- and four-month assessments. [Press release from the University of California, Irvine discussing online prepublication in Cancer Research]

New Technique Boosts Efficiency of Blood Cell Production from Human Stem Cells
Scientists have developed an improved technique for generating large numbers of blood cells from a patient’s own cells. [Press release from the Salk Institute for Biological Studies discussing online prepublication in Stem Cells]

Experts Grow Whole Tooth Units Using Mouse Stem Cells
Scientists said they have created teeth — complete with connective fibers and bones — by using mouse stem cells and successfully transplanted them into mice. [Press release from Reuters discussing online prepublication in PLoS One]

Celprogen Announces Development of Neuronal Stem Cells Derived from Adult Human Brains; May Someday Be an Effective Therapy for Alzheimer’s Patients
Celprogen has developed neuronal stem cells that can be differentiated into neurons as an alternative for cell based therapy for neurological diseases including Alzheimer’s patients. [Celprogen Inc. Press Release]

Researchers Begin First Stem Cell Trials to Treat Eye Diseases
Researchers have begun two clinical trials to determine the safety of stem cell therapy and patients’ ability to tolerate it for the treatment of two common, currently untreatable degenerative eye diseases. [University of California, Los Angeles Press Release]

Study Uses New Stem Cell Therapy in Patients Up to 19 Days After Stroke
The first Texas patient has been enrolled by researchers in the country’s first double-blind clinical trial studying the safety and efficacy of an innovative stem cell therapy that can be given up to 19 days after an ischemic stroke. [The University of Texas Health Science Center at Houston Press Release]


(Ranked by Impact Factor of the Journal)

Functional Regeneration of Respiratory Pathways After Spinal Cord Injury
Experiments present a way to markedly restore the function of a single muscle after debilitating trauma to the central nervous system, through both promoting the plasticity of spared tracts and regenerating essential pathways. [Nature]

MicroRNA-Mediated Conversion of Human Fibroblasts to Neurons
Researchers show that expression of miR-9/9* and miR-124 in human fibroblasts induces their conversion into neurons, a process facilitated by NEUROD2. [Nature]

Genetic Engineering of Human Pluripotent Cells Using TALE Nucleases
Investigators engineered transcription activator–like effector nucleases (TALENs) for five distinct genomic loci. [Nature Biotechnol]

Precise Manipulation of Chromosomes In Vivo Enables Genome-Wide Codon Replacement
Scientists present genome engineering technologies that are capable of fundamentally reengineering genomes from the nucleotide to the megabase scale. [Science]

Epigenetic Memory and Preferential Lineage-Specific Differentiation in Induced Pluripotent Stem Cells Derived from Human Pancreatic Islet Beta Cells
Using two genetic lineage-tracing systems, researchers demonstrate the generation of induced pluripotent stem cell lines from human pancreatic islet beta cells. [Cell Stem Cell]

Human Neural Stem Cell Transplantation Ameliorates Radiation-Induced Cognitive Dysfunction
The potential of using stem cell replacement as a strategy to combat radiation-induced cognitive decline was addressed by irradiating athymic nude rats followed 2 days later by intrahippocampal transplantation with human neural stem cells. [Cancer Res]



Stem Cell Policy Receives Updates
The Executive Board approved revisions to the American Veterinary Medical Association’s policy on stem cells that reflect the changing face of stem cell research and stem cell–based therapies. [The American Veterinary Medical Association, United States]

House Spending Panel Punishes OSTP Over Links to China
The Congress cuts the White House Office of Science and Technology Policy (OSTP)’s 2012 budget by 55%, from the current $6.65 million to $3 million. [White House Office of Science and Technology Policy, United States]

Task Force: No Need to Pull Research Council Out of European Commission
Despite their often tumultuous relationship, there is no need to cut the European Research Council loose from the European Commission and create a new, independent organization to manage it, a task force said in a report issued. [European Research Council, European Union]

NICE Seen at Heart of New UK Drug Pricing System
Britain’s cost-effectiveness health watchdog the National Institute for Health and Clinical Excellence (NICE) expects to play a central role in a value-based pricing system for new medicines due to take effect from 2014, according to its chief executive. [National Institute for Health Clinical Excellence, United Kingdom]


NeoStem Signs Definitive Merger Agreement to Acquire Amorcyte in Equity Transaction
NeoStem, Inc. announced the signing of a definitive merger agreement whereby NeoStem will acquire Amorcyte, Inc. [Neostem, Inc. Press Release]

Family Foundation of Business Leader Invests $4.55 Million In Northwest Biotherapeutics for Promising Clinical Trials In the US and Europe

Northwest Biotherapeutics announced a $4.55 million equity investment on June 28, 2011, by The Richard M. Schulze Family Foundation. [Northwest Biotherapeutics Press Release]

NIH Supports New Research Strategy for Finding a Cure for HIV
An international team led by researchers from the University of California, San Francisco and the nonprofit Vaccine and Gene Therapy Institute has received a major grant from the National Institutes of Health (NIH) to develop a strategy to eradicate HIV from the body. [University of California, San Francisco Press Release]

Hutchinson Center to Lead a $20 Million Research Project to Explore a Potential Cure for HIV Infection
Whether a stem cell transplant using an HIV-infected person’s own genetically modified immune cells can become a cure for the disease is the focus of a new $20 million, five-year research grant award announced by the National Institutes of Health to Fred Hutchinson Cancer Research Center. [Fred Hutchinson Cancer Research Center Press Release]

Cancer Research UK Invests in Future World-Leading Scientists
Cancer Research UK has given a number of prestigious grants to new investigators who are set to become the eminent cancer scientists of the future. [Cancer Research UK Press Release]

European Patent OK’d for iPSC Technology of Kyoto Univ.’s Yamanaka
The European Patent Office has approved a patent for Kyoto University professor Shinya Yamanaka’s technology for creating induced pluripotent stem cells (iPSCs) the university said. [The Mainichi Daily News]

Alnylam Files Clinical Trial Application (CTA) for ALN-PCS, an RNAi Therapeutic Targeting PCSK9 for the Treatment of Severe Hypercholesterolemia
Alnylam Pharmaceuticals, Inc. announced that it has filed a CTA with the Medicines and Healthcare products Regulatory Agency to initiate a Phase I clinical trial with ALN-PCS, an RNAi therapeutic for the treatment of severe hypercholesterolemia. [Alnylam Pharmaceuticals, Inc. Press Release]


Embryonic Stem-Cell Approvals Rise
Research using human embryonic stem- cell lines approved under President Barack Obama is accelerating, boosting a scientific field that’s been dogged by legal and political threats.

Center for Scientific Review; Notice of Closed Meeting (FR Doc No: 2011-17450)

Center for Scientific Review; Notice of Closed Meeting (FR Doc No: 2011-17712)

National Cancer Institute; Notice of Closed Meeting (FR Doc No: 2011-17608)

National Institute of General Medical Sciences; Notice of Closed Meeting (FR Doc No: 2011-17611)

Submission for OMB Review; Comment Request; Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO) (NCI) (FR Doc No: 2011-17750)


April 28-29, 2011: Blood Products Advisory Committee Meeting Transcripts

April 28-29, 2011: Blood Products Advisory Committee Meeting Final Agenda

April 28-29, 2011: Blood Products Advisory Committee Meeting Public Roster

Influenza Virus Vaccine for the 2011 – 2012 Season

Public Workshop – Quarantine Release Errors in Blood Establishments



Draft Guidance for Industry and Food and Drug Administration Staff; Enforcement Policy for Premarket Notification Requirements for Certain In Vitro Diagnostic and Radiology Devices; Availability [Docket No. FDA-2011-D-0476]

Draft Guidance for Industry and FDA Staff on In Vitro Companion Diagnostic Devices; Availability [Docket No. FDA-2011-D-0215]


European Medicines Agency Seeks Views on Genomic Markers in Medicine Development
The European Medicines Agency has released a reflection paper on use of ‘genomic markers’ in the development and testing of human medicines for public consultation.

Public Consultation Opens on the Revised Guideline on Good Distribution Practice of Medicinal Products for Human Use
The European Commission’s Directorate General for Health and Consumer Policy has launched a public consultation on the revised ‘Guideline on Good Distribution Practice of Medicinal Products for Human Use’.


MHRA Annual Report and Accounts 2010/11


Regulatory Framework for Biological
Updated information about the regulatory framework for biological

Australian Regulatory Guidelines for Biologicals (ARGB)
Guidelines detailing the legal arrangements in Australia for the supply and use of human cell and tissue-based therapeutic goods

Therapeutic Goods Orders
Added links to new biologicals TGOs (83, 84, 85, 86 and 87)


NEW Stem Cell Society Singapore Symposium 2011
November 17-18, 2011
Singapore, Singapore

Visit our events page to see a complete list of events in the cell, gene and immunotherapy community.


Lab Technologist – Tissue Culture (STEMCELL Technologies)

Research and Development Technologist, hPSC Media (STEMCELL Technologies)

Scientist (iPSC) (STEMCELL Technologies)

Postdoctoral Position (Nanyang Technological University)

Medical Officer (California Institute for Regenerative Medicine)

Postdoctoral Position (University of California, Davis)

Director, Cell Processing Operations (Hospira Industry)

PhD Scholarship (Tasmania University)

Postdoctoral Fellow (Roswell Park Cancer Institute)

Industrial Postdoctoral Research Fellow (Regenerative Medicine Cell Therapy) (Tissue Regeneration Therapeutics Inc.)

Research Laboratory Technician (Cambridge Centre for Brain Repair)

Postdoctoral Research Fellow (Tshwane University of Technology)

Senior Research Fellowship (Masaryk University)

Junior Research Fellowship (Masaryk University)

Reintegrating/Czech Nationality/ Research Fellowship (Masaryk University)

Microscopy and Image Analysis Specialist (Masaryk University)

PhD Positions in Stem Cell Research (Masaryk University)

PhD Positions in Medical Biology (Masaryk University)

Postdoctoral Fellow – Stem Cell Biology and Immunology (NIH Center for Biomedical Research Excellence)

Graduate Student – Laboratory for Equine and Comparative Orthopedic Research (Louisiana State University)

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